NCT06433219CompletedPhase 2
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 22 May 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 11 Aug 2026
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Diseases
- Ovarian cancer
- NCT number
- NCT06433219
- EU CT number
- 2024-511202-23-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 63
- From 30 Oct 2024 to the primary completion date, 11 Aug 2026
- 85 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known brain metastases, unless clinically stable, that is without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration.
- Organ transplantation, including allogenic stem cell transplant.
Other illness
- Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the platinum administration in either the first or second-line setting.
- History of additional malignancy within 3 years before the date of enrollment.
- Active and/or uncontrolled infection.
- History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
- Patients with history of drug-induced severe cutaneous adverse reaction (SCAR; including but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis \[SJS/TEN\], or drug reaction with eosinophilia and systemic symptoms \[DRESS\]), or dose-limiting immune-mediated reactions related to skin.
Other
- Other Protocol defined exclusion criteria could apply.
Who the study is looking for
- Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent.
- Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening.
- Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be \>6 months, with documented disease progression prior to study entry).
- OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)
- Intolerant to standard of care treatment options or refused standard of care treatment or the participant's treating physician considers that the lack of standard of care treatment is not detrimental for the participant.
- Measurable disease per RECIST v1.1, as assessed by Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
- Other Protocol defined inclusion criteria could apply.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (85)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| St George Private Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Liverpool Hospital - PARENT Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Kantonsspital Frauenfeld - 150509250 Coordinator of this site? Confirm its status | Frauenfeld | Switzerland | Unknown status |
| Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie Coordinator of this site? Confirm its status | Liestal | Switzerland | Unknown status |
| Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Universitaetsspital Zuerich - Klinik fuer Gynaekologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Completed |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari de Girona Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Completed |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Completed |
| Clinique Victor Hugo Coordinator of this site? Confirm its status | Le Mans | France | Completed |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Coordinator of this site? Confirm its status | Paris | France | Completed |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 15 | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Groupe Hospitalier Saint Vincent Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Addenbrooke's Hospital - Dept of Oncology Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Beatson West of Scotland Cancer Centre - Dept of Medical Oncology Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Royal Surrey County Hospital - Dept of Oncology Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| St James's University Hospital - Dept of Oncology Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Marsden Hospital-London - Dept of Haematology/Oncology Research Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's Hospital - Dept of Medical Oncology Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals - NIHR/Wellcome Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie Hospital - Dept of Oncology Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Mount Vernon Hospital - Dept of Oncology Coordinator of this site? Confirm its status | Northwood | United Kingdom | Unknown status |
| Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey) Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| The Lady Davis Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Ospedaliera per l Emergenza Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Completed |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Completed |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Jagiellonskie Centrum Innowacji Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Instytut MSF Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Europejskie Centrum Zdrowia Otwock Sp. Z.o.o. Coordinator of this site? Confirm its status | Otwock | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Virginia Cancer Specialists PC Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| NEXT Oncology- Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California San Francisco - UCSF Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.